Department of Health and Human Services July 13, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Evaluation of In Vitro Tests for Identifying Eye Injury Hazard Potential of Chemicals and Products: Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is planning to convene an independent scientific peer review panel (Panel) to assess the validation status of in vitro tests and integrated non-animal testing strategies proposed for identifying eye injury hazard potential of chemicals and products. On behalf of ICCVAM, NICEATM requests nominations of scientific experts who can be considered for the Panel and submission of data from substances tested in in vitro tests for identifying eye injury hazard potential. Of particular interest are data generated in the short-time exposure (STE) (Takahashi et al., 2008) and isolated rabbit eye (IRE) (ICCVAM, 2006, 2010a) tests and data from approaches using two or more in vitro tests. However, NICEATM requests data from other tests including, but not limited to, the bovine corneal opacity and permeability (BCOP), isolated chicken eye (ICE), hen's egg testchorioallantoic membrane (HET-CAM), Cytosensor microphysiometer (CM), fluorescein leakage (FL), SkinEthicTM human corneal epithelium, and EpiOcularTM tests. If available, corresponding in vivo data for these substances are also requested, including data from any ethical human or animal studies or accidental human exposures.
Request for Public Comment on a Nomination to the Office of Health Assessment and Translation
The NTP requests comments on Air Pollution and Children's Health, which was nominated for a possible evaluation by the Office of Health Assessment and Translation (OHAT). This nomination focuses on substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') related to traffic/near road air pollution and their association with emerging children's health outcomes.
Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 250 mg.
Determination That TOPOTECAN INJECTION (Topotecan Hydrochloride) 1 Milligram (Base)/1 Milliliter, 3 Milligram (Base)/3 Milliliter, 4 Milligram (Base)/4 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, if all other legal and regulatory requirements are met.
Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 6, 2012 (77 FR 40069). The document announced FDA's intention to take enforcement action against all unapproved single-ingredient, immediate-release drug products that contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The document was published with an incorrect Web link. This document corrects that error.
Statement of Cooperation Between the Food and Drug Administration and the Secretaria of Health of the United Mexican States: Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported From Mexico to the United States
The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh and frozen molluscan shellfish harvested from aquacultured and wild populations that are now or may be exported into the United States.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Devices: The Pre- Submission Program and Meetings with FDA Staff.'' The purpose of this guidance is to describe the Pre-Submission program (formerly the pre- Investigational Device Exemption (IDE) program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). In addition, the guidance provides recommendations regarding information that should be included in a Pre-Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a meeting with review staff. This draft guidance is not final nor is it in effect at this time.
Food and Drug Administration/Xavier University Global Outsourcing Conference
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\ days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows:
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2013, Hospice Quality Reporting Requirements, and Survey and Enforcement Requirements for Home Health Agencies
This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national standardized 60- day episode rates, the national per-visit rates, the low-utilization payment amount (LUPA), and outlier payments under the Medicare prospective payment system for home health agencies effective January 1, 2013. This rule also proposes requirements for the Hospice quality data reporting program. This proposed rule would also establish requirements for unannounced, standard and extended surveys of home health agencies (HHAs) and provide a number of alternative (or intermediate) sanctions that could be imposed if HHAs were out of compliance with Federal requirements. This proposed rule would set forth alternative sanctions that could be imposed instead of or in addition to termination of the HHA's participation in the Medicare program, which could remain in effect up to a maximum of 6 months, until the HHA achieved compliance with the HHA Conditions of Participation (CoPs), or until the HHA's provider agreement was terminated.
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